A Phase III Open-Label Extension Study to Assess the Long-Term Safetyand Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy(DMD) who completed the SIDEROS study - SIDEROS-E

SANTHERA PHARMACEUTICALS0 个研究点目标入组 266 人开始时间: 2021年1月22日最近更新: 2021年8月17日

试验速览

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•Completion of the SIDEROS study at Visit 8/ Week 78.
•Signed and dated Informed Consent Form.
•inclusion criteria for the optionsal continued treatment with idebenone beyond Visit 4 of SIDEROS-E study:
•1. completion of Visit 4 / week 78 of Sideros-E study
•2. Signed and dated Informed Consent Form for continued treatment
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Patients who discontinued SIDEROS study prematurely (i.e. did not attend all visits from V1 to V8).
•2. Safety, tolerability or other issues arising during the course of the SIDEROS study which in the opinion of the Investigator may put the
•patient at significant risk or may interfere significantly with the patient's
•participation in the SIDEROS-E study.
•3. Use of any investigational drug other than the study medication.
•Exclusion criteria for the optional continued treatment with idebenone
•beyond Visit 4/ Week 78 of SIDEROS-E study:
•1. Premature withdrawal from SIDEROS-E study before Visit 4/ Week 78
•2. Any conditions, which, in the opinion of the Investigator might trigger
•a negative risk-benefit assessment for the patient
•3. Use of any Investigational drug other than the study medication

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